Risperidone 4mg Film-Coated Tablets
Package leaflet: Information for the patients Risperidone 0.5 mg film-coated tablets Risperidone 1 mg film-coated tablets Risperidone 2 mg film-coated tablets Risperidone 3 mg film-coated tablets Risperidone 4 mg film-coated tablets Risperidone 6 mg film-coated tablets
(risperidone)
The name of this medicine is Risperidone 0.5, 1,2, 3, 4 & 6 mg Film-Coated Tablets which will be referred to as Risperidone Tablets throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet
1. What Risperidone Tablets are and what they are used for
2. What you need to know before you take Risperidone Tablets.
3. How to take Risperidone Tablets
4. Possible side effects
5. How to store Risperidone Tablets
6. Contents of the pack and other information_
1. What Risperidone Tablets are and what they are used for
Risperidone Tablets belong to the group of medicines called ‘anti-psychotics’.
Risperidone Tablets are used to treat the following:
• Schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused
• Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive. Mania occurs in an illness called “bipolar disorder”
• Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’s dementia, who harm themselves or others. Alternative (non-drug) treatments should have been used previously
• Short-term management (up to 6 weeks) of long-term aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorder.
2. What you need to know before you take Risperidone Tablets
Do not take Risperidone Tablets if you:
• are allergic (hypersensitive) to risperidone or any of the other ingredients in
Risperidone Tablets (listed in section 6).
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Risperidone Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone Tablets if:
• you have a heart problem. Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure. Risperidone Tablets may cause low blood pressure. Your dose may need to be adjusted.
• you know of any factors which would favour you having a stroke, such as high blood pressure, cardiovascular disorder or blood vessel problems in the brain
• you have Parkinson’s disease or dementia.
• you are diabetic.
• you have epilepsy (seizures or fits).
• you are a man and you have ever had a prolonged or painful erection. If you experience this while taking Risperidone Tablets, contact your doctor straight away.
• you have problems controlling your body temperature or overheating.
• you have kidney problems.
• you have l iver problems.
• you have an abnormally high level of the hormone prolactin in your blood or if you have a tumour which is possibly dependent on prolactin.
• you or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.
Tell your doctor immediately if you experience:
• involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of risperidone may be needed.
• fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome"). Immediate medical treatment may be needed.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidone Tablets
Risperidone Tablets may cause you to gain weight.
As diabetes mellitus or worsening of pre-existing diabetes mellitus have been seen with patients taking Risperidone Tablets, your doctor should check for signs of high blood sugar.
In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.
During an operation on the eye for cloudiness of the lens (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the coloured part of the eye) may become floppy during surgery and that may lead to eye damage. If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
Be aware that risperidone may mask signs and symptoms of drug overdose and of conditions such as intestinal obstruction, brain tumor, and Reye's syndrome (a dangerous neurological condition that may follow viral infections, usually occurring in children).
Elderly people with dementia
In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if you have dementia caused by a stroke.
During treatment with risperidone you should frequently see your doctor.
Medical treatment should be sought straight away if you of your care-giver notice a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time. These may be signs of a stroke.
Children and adolescents
Before treatment is started in conduct disorder, other causes of aggressive behaviour should have been ruled out.
If during treatment with risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.
• medicines to treat elevated blood pressure. Risperidone can lower blood pressure
• medicines for Parkinson’s disease (such as levodopa)
• water tablets (diuretics) used for heart problems or swelling of parts of your body due to a build up of too much fluid (such as furosemide or chlorothiazide). Risperidone taken by itself or with furosemide, may have an increased risk of stroke or death in elderly people with dementia.
The following medicines may reduce the effect of risperidone:
• Rifampicin (a medicine for treating some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital
If you start or stop taking such medicines you may need a different dose of risperidone.
The following medicines may increase the effect of risperidone:
• Quinidine (used for certain types of heart disease)
• Antidepressants such as paroxetine, fluoxetines, tricyclic antidepressants
• Medicines known as beta blockers (used to treat high blood pressure)
• Phenothiazines (e.g. used to treat psychosis or to calm down)
• Cimetidine, ranitidine (blockers of the acidity of the stomach).
If you start or stop taking such medicines you may need a different dose of risperidone.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidone Tablets.
Risperidone tablets with food, drink and alcohol
You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperidone Tablets.
Pregnancy, breast-feeding and fertility
• if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide if you can take it.
• The following symptoms may occur in newborn babies, of mothers that have used Risperidone Tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty
in feeding. If your baby develops any of these symptoms you may need to contact your doctor
• Risperidone can raise your levels of a hormone called "Prolactin" that may imact fertility (see Possible side effects)
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Dizziness, tiredness and vision problems may occur during treatment with Risperidone Tablets. Do not drive or use any tools or machines without talking to your doctor first.
Risperidone tablets contains lactose
The film-coated tablets contains contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Risperidone 2 mg Film-Coated Tablets also contain the colouring Sunset Yellow which may cause allergic reactions.
3. How to take Risperidone Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is as follows:
For the treatment of schizophrenia:
Adults
• The usual starting dose is 2 mg per day, this may be increased to 4 mg per day on the second day.
• Your dose may then be adjusted by your doctor depending on how you respond to the treatment.
• Most people feel better with daily doses of 4 to 6 mg.
• This total daily dose can be divided into either one or two doses a day. Your doctor will tell you which is best for you.
Elderly people
• Your starting dose will normally be 0.5 mg twice a day.
• Your dose may then be gradually increased by your doctor to 1 mg to 2 mg twice a day.
• Your doctor will tell you which is best for you.
Children and adolescents
• Children and adolescents under 18 years old should not be treated with Risperidone Tablets for schizophrenia.
For the treatment of mania:
Adults
• Your starting dose will usually be 2 mg once a day.
• Your dose may then be gradually adjusted by your doctor depending on how you respond to the treatment.
• Most people feel better with doses of 1 to 6 mg once a day.
Elderly people
• Your starting dose will usually be 0.5 mg twice a day.
• Your dose may then be gradually adjusted by your doctor to 1 mg to 2 mg twice a day depending on how much you respond to the treatment.
Children and adolescents
• Children and adolescents under 18 years old should not be treated with Risperidone Tablets for bipolar mania.
For the treatment of long-standing aggression in people with Alzheimer’s dementia: Adults (including elderly people)
• Your starting dose will normally be 0.25 mg twice a day.
• Your dose may then be gradually adjusted by your doctor depending on how you respond to the treatment.
• Most people feel better with 0.5 mg twice a day. Some patients may need 1 mg twice a day.
Treatment duration in patients with Alzheimer’s dementia should be not more than 6 weeks.
For the treatment of conduct disorder:
The dose will depend on your child’s weight:
For children who weigh less than 50 kg
• The starting dose will normally be 0.25 mg once a day
• The dose may be increased every other day in steps of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg once a day.
For children who weigh 50 kg or more
• The starting dose will normally be 0.5 mg once a day
• The dose may be increased every other day in steps of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg once a day.
Before treatment is started your, or your child’s body weight may be measured and it may be
regularly monitored during treatment.
Other medicines and risperidone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
It is especially important to talk to your doctor or pharmacist if you are taking any of the
following:
• medicines that work on your brain such as to help you calm down (benzodiazepines) or some medicines for pain (opiates), medicines for allergy (some antihistamines), as risperidone may increase the sedative effect of all of these
• medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems (such as quinidine), allergies (antihistamines), some antidepressants or other medicines for mental problems
• medicines that cause a slow heart beat
• medicines that cause low blood potassium (e.g. certain diuretics) page i
Treatment duration in patients with conduct disorder should be not more than 6 weeks.
Children under 5 years old should not be treated with Risperidone Tablets for conduct disorder.
People with kidney or liver problems
Regardless of the disease to be treated, all starting doses and following doses of risperidone should be halved. Dose increases should be slower in these patients. Risperidone should be used with caution in this patient group.
How to take Risperidone Tablets
Always take Risperidone Tablets exactly as your doctor has told you to do so. You should check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how much medicine to take and for how long. This will depend on your condition and varies from person to person. The amount of medicine you should take is explained under the ‘How much to take’ sub-heading.
You should swallow your tablet with a drink of water.
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If you take more Risperidone Tablets than you should
• See a doctor right away. Take the medicine pack with you.
• In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems standing and walking, feel dizzy due to low blood pressure, or have abnormal heart beats or fits.
If you forget to take Risperidone Tablets
If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor.
Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Risperidone Tablets
You should not stop taking this medicine unless told to do so by your doctor. Your symptoms may return. If your doctor decides to stop this medicine, your dose may be decreased gradually over a few days.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Risperidone Tablets can cause side effects, although not everybody
gets them.
Tell your doctor immediately if you:
• Experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any if these symptoms seek medical advice immediately.
• Have dementia and experience a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time. These may be signs of a stroke.
• Experience fever, muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be needed.
• Are a man and experience prolonged or painful erection. This is called priapism. Immediate medical treatment may be needed.
• Experience involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of risperidone may be needed.
• Experience severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash or drop in blood pressure.
• Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis)
• Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)
• Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis)
• Parkinsonism. This is a medical term that includes many symptoms. Each individual symptom may occur less frequently than in 1 in 10 people. Parkinsonism includes: increase in saliva secretion or watery mouth, musculoskeletal stiffness, drooling, jerks when bending the limbs, slow, reduced or impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking, persistent blinking in response to tapping of the forehead (an abnormal reflex).
• Unresponsive to stimuli, loss of consciousness, sudden swelling of lips and eyes along with difficulty breathing, sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of slurred speech that last for less than 24 hours (these are called mini-strokes or strokes), involuntary movements of face, arms, or legs, ringing in ears, face oedema.
• The signs and symptoms of due to decreased blood cells e. g. unexplained brushing or bleeding sore, throat, mouth ulcer, sudden fever.
The following side effects have also been reported:
Very Common (may affect more than 1 in 10 people):
• Headache, sleepiness.
Common (may affect up to 1 in 10 people):
• Drowsiness, fatigue, restlessness, inability to sit still, irritability, anxiety, sleepiness, poor attention, feeling exhausted, sleep disorder
• Vomiting, diarrhoea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth
• Weight increased, increase in body temperature
• Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages, blurred vision, nose congestion, nose bleeding, cough
• urinary i ncontinence, bed wetting
• Muscle spasm, involuntary movements of face or arms and legs, joint pain, back pain, swelling of arms and legs, pain in arms and legs
• Rash, skin redness
• Fast beating heart, chest pain
• Blood prolactin hormone level increased.
• shaking
• Dyskinesia: This is a condition involving involuntary muscle movements, and can include repetitive, spastic or writhing movements, or twitching.
• Dystonia: This is a condition involving slow or sustained involuntary contraction of muscles.
• While it can involve any part of the body (and may result in abnormal posture), dystonia often involves muscles of the face, including abnormal
• redness and irritation of the thin membrane that covers the eye movements of the eyes, mouth, tongue or jaw.
• depression
• agitation
• bronchitis
• urinary tract infection
• sinusitis
• hypertension
• high blood pressure
• ear infection
• conjunctivitis
• chest pain.
Uncommon (may affect up to 1 in 100 people):
• Excessive drinking of water, stool incontinence, thirsty, very hard faeces, hoarseness or voice disorder
• Lung infection caused by inhaling of food into the breathing passages, bladder infection,
“pink eye”, sinus infection, viral infection, tonsil infection, infection under
the skin, eye infection, gastroenteritis (stomach infection), yeast infection of nails
• Abnormal electrical conduction of the heart, drop in blood pressure after standing, low blood pressure, feeling dizzy after changing body position, abnormal electric activity tracing of the heart (ECG), abnormal heart rhythm, awareness of heart beating, heart rate increased
• Pain when passing urine, frequent passing of urine
• Difficulty emptying the bladder
• Confused, disturbance in attention, low level of consciousness, excessive sleep, nervousness, elated mood (mania), lack of energy
• Diabetes or worsening of diabetes, Blood sugar increased
• Increased cholesterol in your blood
• Condition in which the number of white blood cells called neutrophils is abnormally low.
• Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, musculoskeletal chest pain, chest discomfort
• Skin lesion, skin disorder, dry skin, intense itching of skin, acne, hair loss, skin discolouration, thickening of skin, flushing, reduced
skin sensitivity to pain or touch, inflammation of oily skin
• Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, discharge of milk (galactorrhoea), enlargement of breast in men, decreased sexual drive, irregular menstruation, vaginal discharge
• Fainting, gait disturbance, sluggishness, feeling “out of sorts”, balance disorder, allergy, oedema, chills, abnormal coordination
• loss or abnormal sense of taste
• Painful oversensitivity to light, increased blood flow to the eye, eye swelling, dry eye, increase in tears
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• Breathing passage disorder, lung congestion, crackly lung noise, congestion of breathing passages, trouble speaking, difficulty swallowing, cough with sputum, coarse/whistling sound during breathing, flu-like illness
• flatulence, cystitis (burning irritation on urination), cellulitis, onychomycosis (yeast (fungal nail) infection), ear pain tinnitus, vertigo, nightmares, eczema, urticarial, (nettle rash).
Rare (may affect up to 1 in 1,000 people):
• Inability to reach orgasm, menstrual disorder
• D an d ru ff
• Drug allergy, coldness in extremeties (fingers and toes), lip swelling, lip inflammation
• Glaucoma, eyelid margin crusting, eye rolling
• Lack of emotion
• Change in consciousness with increased body temperature and twitching of muscles, oedema all over the body, body temperature decreased
• Fast shallow breathing, trouble breathing during sleep
• Obstruction of intestine,
• Reduced blood flow to the brain
• Low blood sugar
• tremor of head
• Decrease in white blood cells, inappropriate secretion of a hormone that controls urine volume
• Movement disorder
• Diabetic ketoacidosis (coma due to uncontrolled diabetes, and anaphylaxis serious allergic reaction)
• Coma due to uncontrolled diabetes
• Severe allergic reaction resulting in difficulty in breathing and shock
• No granulocytes (a type of white blood cell to help you against infection)
• Prolonged and painful erection
• Dangerously excessive intake of water.
• High blood triglycerides (a fat)
• Eye movement disorders
• Cheilitis
Very rare (may affect up to 1 in 10,000 people):
• Life threatening complications of uncontrolled diabetes.
• Lack of bowel muscle movement that causes blockage.
• Ileus
• Angioedema.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Risperidone Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, carton, or bottle. The expiry date refers to the last day of that month.
Store your tablets in the original package. This medicinal product does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Risperidone Tablets contain:
The active ingredient is risperidone. There are 6 strengths available containing 0.5 mg, 1mg, 2mg, 3mg, 4mg and 6mg risperidone per tablet.
The other ingredients are: starch, microcrystalline cellulose (E460), lactose monohydrate, sodium starch glycolate (Type A), and magnesium stearate.
Risperidone 0.5 mg Tablets also contain Opadry Brown. Opadry Brown contains Hypromellose (E464), Titanium Dioxide (E171), Polyethylene Glycol and Iron Oxide Red (E172).
Risperidone 1 mg Tablets also contain Opadry White. Opadry White contains Hypromellose (E464), Titanium Dioxide (E171) and Polyethylene Glycol.
Risperidone 2 mg Tablets also contain Opadry Orange. Opadry Orange contains Hypromellose (E464), Titanium Dioxide (E171), Polyethylene Glycol and Sunset Yellow (E110).
Risperidone 3 mg Tablets also contain Opadry Yellow. Opadry Yellow contains Hypromellose (E464), Titanium Dioxide (E171), Polyethylene Glycol and Quinoline Yellow (E104).
Risperidone 4 mg Tablets also contain Opadry Green. Opadry Green contains Hypromellose (E464), Titanium Dioxide (E171), Polyethylene Glycol, Quinoline Yellow (E104) and Indigo Carmine (E104).
Risperidone 6 mg Tablets also contain Opadry Yellow. Opadry Yellow contains Hypromellose (E464), Titanium Dioxide (E171), Polyethylene Glycol and Quinoline Yellow (E104).
What Risperidone Tablets look like and the contents of the pack:
Risperidone 0.5 mg Film-Coated Tablets:
Brown coloured, circular, biconvex, film-coated tablets with '0.5' embossed on one side and plain on the other. Available in packs of 20 tablets.
Risperidone 1 mg Film-Coated Tablets:
White coloured, round, film-coated tablets, with '1' embossed on one side and plain on the other. Available in packs of 60 tablets.
Risperidone 2mg Film-Coated Tablets:
Orange coloured, round, film-coated tablets, with '2' embossed on one side and plain on the other. Available in packs of 60 tablets.
Risperidone 3 mg Film-Coated Tablets:
Yellow coloured, round, film-coated tablets, with '3' embossed on one side and plain on the other. Available in packs of 60 tablets.
Risperidone 4 mg Film-Coated Tablets:
Green coloured, round, film-coated tablets, with '4' embossed on one side and plain on the other. Available in packs of 60 tablets.
Risperidone 6 mg Film-Coated Tablets:
Yellow coloured, capsule shaped, biconvex, film-coated tablets, with '6' embossed on one side and plain on the other. Available in packs of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
The Product Licence holder is Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW.
The manufacturer responsible for batch release is Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium.
This information is available in alternative formats upon request.
This leaflet was last revised in 09/2015.